Skip to contentApplication 211783
- Type
- ANDA
- Sponsor
- CHEMO RESEARCH SL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESTRADIOL | ESTRADIOL | GEL;TRANSDERMAL | 0.1% | No | No |
| 002 | ESTRADIOL | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (0.5GM/PACKET) | No | No |
| 003 | ESTRADIOL | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (1GM/PACKET) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70700-143 | Estradiol | Estradiol Gel 0.1% | Xiromed, LLC | ANDA | Current |
| 70700-144 | Estradiol | Estradiol Gel 0.1% | Xiromed, LLC | ANDA | Current |
| 70700-145 | Estradiol | Estradiol Gel 0.1% | Xiromed, LLC | ANDA | Current |
| 70700-194 | Estradiol | Estradiol Gel 0.1% | Xiromed, LLC | ANDA | Current |
| 70700-195 | Estradiol | Estradiol Gel 0.1% | Xiromed, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72028 | ORIG | 2022-09-07 |